genitourinary syndrome of menopause
Conditions
Interventions
intervention group:vaginal application of one tube of sodium hyaluronate gel, once every day for the first two weeks and once every 3 days for the following two weeks, with four weeks in total.
placebo control group:vaginal application of one tube of placebo, once every day for the first two weeks and once every 3 days for the following two weeks, with four weeks in total.
Sponsors
Peking University First Hospital, Department of Gynaecology and Obstetrics
Eligibility
Sex/Gender
Female
Age
45 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. aged between 45-70 (with boundary included) 2. menopause women (with or without hysterectomy) with at least one of following criteria met: a. amenorrhea over 12 months if no hysterectomy was done b. serum FSH level above 40IU/L if currently undergoing amenorrhea between 6-12 months, or underwent hysterectomy before menopause c. underwent bilateral oophorectomy over 6 months ahead of baseline visit 3. vaginal discharge pH>5.0 4. underwent at least one of the following symptoms and degree of symptoms evaluated as moderate or severe using the VASQ rating scale a. vaginal dryness at least once a week b. vulvovaginal itching at least once a week c. sensation of stimulation at least once a week d. feeling of pain in vulvovaginal area at least once a week e. coital pain at least once a week 5. participants could voluntarily avoid the use of either antibiotics, pre/probiotics, drugs containing estrogen unless permitted. 6. participants are involved in this study voluntarily and agree to sign informed consent in written form.
Exclusion criteria
Exclusion criteria: 1. patient suffering from bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis vaginitis, lichen sclerosus, vulvovaginal lichen planus, precancerous cervical lesion, vaginitis caused by radiotherapy, etc. 2. systematic or topical use of any antibiotics within 2 weeks ahead of randomisation 3. experience of invasive vaginal procedure, pelvic or cervical operation or observable vaginal lesion through vaginal examination within 2 weeks ahead of randomisation. 4. patients diagnosed with severe respiratory, circulatory, endocrine, immune, digestive, nervous system diseases or pelvic organ prolapse caused by dysfunction of pelvic floor or any other diseases which may cause intolerance to this clinical trials 5. use of any estrogen preparations within 2 months ahead of randomisation, such as estrogen injection, estrogen implant rod, progesterone injection, progesterone implant, etc. 6.use of drugs that may significantly affect the metabolism of estrogen and progesterone within 2 months ahead of randomisation, such as androgens, synthetic steroids, oral estrogen, oral progesterone, dehydroepiandrosterone (DHEA), simple estrogen or estrogen/progesterone transdermal drugs, etc. 7. use of intrauterine progesterone treatment and intravaginal hormone drugs (ring, cream, gel or tablet) within 1 month before randomisation. 8. patients currently receiving investigational drug treatment or planning to participate in other clinical trials of other drugs or devices. 9. Unidentified vaginal bleeding. 10. Individuals with allergic constitution and allergies to experimental drugs or their ingredients. 11. History of adverse reactions to vaginal hyaluronic acid; 12. use of any vaginal moisturizers, irritants, irritants, vaginal prebiotics or probiotics or cleaning agents within 1 month ahead of randomisation. 13. Those who are unable to follow the protocol requirements and steps, or any other subjects who have been judged by the researcher to be unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement of symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| improvement of vaginal atrophy symptoms questionnaire, vaginal health index score, vaginal pH, vaginal maturation index and female sexual function index compared to baseline;vital signs and physical examination; | — |
Countries
China
Contacts
Public ContactXiao Bingbing
Peking University First Hospital, Department of Gynaecology and Obstetrics
Outcome results
None listed